FDA Creates Four New Drug Chemistry Divisions For CMC Evaluation
Executive Summary
FDA's restructuring of the Office of New Drug Chemistry includes the establishment of four new divisions to separate out pre- and post-marketing functions
You may also be interested in...
CMC Regulatory Paradigm Shift To Be Reviewed By PQRI
FDA will look to the Product Quality Research Institute to help with the manufacturing science issues involved in reshaping the agency's NDA chemistry, manufacturing and controls regulatory paradigm
CMC Regulatory Paradigm Shift To Be Reviewed By PQRI
FDA will look to the Product Quality Research Institute to help with the manufacturing science issues involved in reshaping the agency's NDA chemistry, manufacturing and controls regulatory paradigm
GMP Oversight Will Have FDA-Wide Coordination Under Rx Quality Council
FDA's newly formed Council on Pharmaceutical Quality will oversee implementation of the agency's pharmaceutical current good manufacturing practices initiative for the 21st century